Table 1.
Baseline demographics, disease characteristics, and prior anticancer therapy in patients with or without stage IIIA-N2 NSCLC
| Patients with stage IIIA-N2 NSCLC |
Patients without stage IIIA-N2 NSCLCa |
|||
|---|---|---|---|---|
| Durvalumab (n = 197) | Placebo (n = 90) | Durvalumab (n = 279) | Placebo (n = 147) | |
| Median age (range), years | 65.0 (33-83) | 65.0 (23-90) | 62.0 (31-84) | 63.0 (40-89) |
| Age ≥65 years, n (%) | 112 (56.9) | 46 (51.1) | 103 (37.0) | 61 (41.5) |
| Male, n (%) | 132 (67.0) | 67 (76.7) | 202 (72.4) | 97 (66.0) |
| Race, n (%) | ||||
| White | 140 (71.1) | 59 (65.6) | 197 (70.6) | 98 (66.7) |
| Black or African American | 4 (2.0) | 1 (1.1) | 8 (2.9) | 1 (0.7) |
| Asian | 50 (25.4) | 29 (32.2) | 70 (25.1) | 43 (29.3) |
| Other/missing | 3 (1.5) | 1 (1.1) | 4 (4.4) | 5 (3.4) |
| Median weight (range), kg | 70.0 (37-133) | 69.0 (38-128) | 68.5 (34-175) | 67.0 (40-121) |
| WHO performance status, n (%) | ||||
| 0 | 99 (50.3) | 45 (50.0) | 135 (48.4) | 69 (46.9) |
| 1 | 97 (49.2) | 44 (48.9) | 143 (51.3) | 78 (53.1) |
| Missing | 1 (0.5) | 1 (1.1) | 1 (0.4) | 0 (0) |
| Histology | ||||
| Squamous | 88 (44.7) | 36 (40.0) | 136 (48.7) | 66 (44.9) |
| Non-squamous | 109 (55.3) | 54 (60.0) | 143 (51.3) | 81 (55.1) |
| AJCC disease stage | ||||
| IIIA | 197 (100) | 90 (100) | 55 (19.7) | 35 (23.8) |
| IIIB | 0 | 0 | 212 (76.0) | 107 (72.8) |
| Other | 0 | 0 | 12 (4.3) | 5 (3.4) |
| EGFR/ALK aberration status, n (%) | ||||
| Negative | 130 (66.0) | 63 (70.0) | 187 (67.0) | 102 (69.4) |
| Positive | 12 (6.1) | 7 (7.8) | 17 (6.1) | 7 (4.8) |
| Unknownb | 55 (27.9) | 20 (22.2) | 75 (26.9) | 38 (25.9) |
| PD-L1 expression level, n (%) | ||||
| <25% | 79 (40.1) | 43 (47.8) | 108 (38.7) | 62 (42.2) |
| ≥25% | 45 (22.8) | 14 (15.6) | 70 (25.1) | 30 (20.4) |
| Unknownb | 73 (37.1) | 33 (36.7) | 101 (36.2) | 55 (37.4) |
| Prior radiotherapy (Gy), n (%) | ||||
| <54 | 0 | 3 (1.1) | 0 | |
| ≥54-≤66 | 180 (91.4) | 86 (95.6) | 262 (93.9) | 131 (89.1) |
| >66-≤74 | 17 (8.6) | 4 (4.4) | 13 (4.7) | 15 (10.2) |
| >74 | 0 | 0 | 0 | 0 |
| Missing | 0 | 0 | 1 (0.4) | 1 (0.7) |
| Prior cytotoxic chemotherapy, n (%) | ||||
| Adjuvant | 0 | 0 | 3 (1.1) | 1 (0.7) |
| Induction | 38 (19.3) | 19 (21.1) | 85 (30.5) | 49 (33.3) |
| Definitive | 197 (100) | 90 (100) | 278 (99.6) | 146 (99.3) |
| Not applicable | 0 | 0 | 1 (0.4) | 0 |
| Prior definitive CRT chemotherapy regimen, n (%)c | 196 (99.5)c | 90 (100)c | 277 (99.3)c | 146 (99.3)c |
| Cisplatin-based | 103 (52.6) | 51 (56.7) | 163 (58.8) | 78 (53.4) |
| Carboplatin-based | 91 (46.4) | 38 (42.2) | 108 (39.0) | 64 (43.8) |
| Cisplatin/carboplatin-based | 2 (1.0) | 1 (1.1) | 6 (2.2) | 4 (2.7) |
| Best response to prior therapy, n (%)d | ||||
| Complete response | 3 (1.5) | 1 (1.1) | 6 (2.2) | 6 (4.1) |
| Partial response | 94 (47.7) | 33 (36.7) | 143 (51.3) | 79 (53.7) |
| Stable disease | 100 (50.8) | 53 (58.9) | 123 (44.1) | 62 (42.2) |
| Progressive disease | 0 | 0 | 2 (0.7) | 0 |
| Not evaluable/applicable | 0 | 3 (3.3) | 5 (1.8) | 0 |
| Time from radiotherapy end to randomization, n (%) | ||||
| <14 days | 45 (22.8) | 22 (24.4) | 75 (26.9) | 40 (27.2) |
| ≥14 days | 152 (77.2) | 68 (75.6) | 204 (73.1) | 107 (72.8) |
AJCC, American Joint Committee on Cancer; ALK, anaplastic lymphoma kinase; CRT, chemoradiotherapy; EGFR, epidermal growth factor receptor; Gy, units of gray; NSCLC, non-small-cell lung cancer; PD-L1, programmed cell death-ligand 1; WHO, World Health Organization.
a
Patients with all other stages (including stages IIIA-N0/N1 and IIIB).
b
No sample collected or no valid test result.
c
Based on the definitive platinum-based chemotherapy regimen only.
d
Based on the last cycle of therapy before entering the study.